Radiopharmaceutical quality assurance is a critical component in nuclear medicine to ensure patient safety and diagnostic efficacy. One such agent, Myoview (technetium (Tc-99m) tetrofosmin), requires careful radiochemical purity (RCP) testing prior to administration.

This blog post explains the critical quality control (QC) process for Myoview (Technetium Tc99m Tetrofosmin), a radiopharmaceutical used in cardiac imaging. All chromatography was conducted using a 35:65 Acetone:Dichloromethane mobile phase.

A comparative quality control evaluation using Molpure SG TLC-400 strips with data collected from different Pharmacy Lots (A, B, and C) and trials conducted.

Instant Thin-Layer Chromatography (ITLC) was performed using Molpure SG TL-400 strips. The % tagged radioactivity was calculated using the following formula:

% Tagged = (Middle CPM ÷ (Top + Middle + Bottom CPM)) × 100

The Middle region of the strip corresponds to the desired Myoview complex, while the Top and Bottom represent impurities.

The minimum accepted purity for Myoview is 90%.

What We're Looking For:

1. The Starting Line (The Origin): This is where we spot the Myoview. Any radioactivity that stays put here (doesn't move with the solvent) is typically Reduced Hydrolyzed Tc-99m. These are impurities that didn't successfully bind to the tetrofosmin molecule.
2. The Middle (The Myoview Spot): The Tc-99m Tetrofosmin (Myoview) itself will travel a specific distance up the strip, usually about halfway to three-quarters of the way.
3. The Solvent Front: Any radioactivity that dashes all the way to the top of the strip, right along with the solvent front, is typically Free Tc-99m Pertechnetate. This is an unreacted technetium that didn't incorporate into the Myoview. 

The radiochemical purity (RCP) of the Myoview preparation is calculated as:

RCP (%)=Activity of Tc-99m Tetrofosmin (Middle Section)​ / Total Activity (Bottom + Middle + Top Sections) ×100%

The effect of applying sample on the rough or smooth side of Molpure TLC strips, indicated that there is no impact on the test results.

The quality control testing of Myoview (Tc-99m Tetrofosmin) using Molpure SG TLC-400 strip consistently demonstrated radiochemical purities well above the minimum 90% threshold across multiple pharmacy lots and trial conditions. The results further show no significant difference between applying the sample on the rough or smooth side of the TLC strip, confirming flexibility in application without compromising test integrity.

These findings reinforce the reliability, reproducibility, and suitability of Molpure SG TLC-400 strips for routine Myoview QC testing — supporting safe and effective nuclear imaging practices.